DEVICE: TSKgel G7 β-Thal. HSi (04560189283114)

Device Identifier (DI) Information

TSKgel G7 β-Thal. HSi
N/A
In Commercial Distribution

TOSOH CORPORATION
04560189283114
GS1

1
690571724 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Haemoglobin A2 (HbA2) IVD, kit, electrophoresis A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype A2 (HbA2) in a clinical specimen using an electrophoresis method.
Haemoglobin F (HbF) IVD, kit, electrophoresis A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype F (HbF), also known as foetal haemoglobin, in a clinical specimen using an electrophoresis method.
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FDA Product Code

[?]
Product Code Product Code Name
JPD Hemoglobin A2 Quantitation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 4 and 15 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a18992cf-1788-4307-9ae9-fcb2c7337678
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
614-317-1909
Levent.durukan@tosoh.com
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